Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06970951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'UTAA91 injection'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'About 1 year', 'description': 'The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0).'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'About 1 year', 'description': 'Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug'}, {'measure': 'Tmax', 'timeFrame': 'About 1 year', 'description': 'Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection'}, {'measure': 'Disease remission rate', 'timeFrame': 'About 3 months', 'description': 'The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA09 injection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus', 'Rheumatoid Arthritis', 'Dry Syndrome', 'Idiopathic Inflammatory Myopathies', 'Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with relapsed/refractory autoimmune inflammatory diseases (AID).', 'detailedDescription': "Following the signing of the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.\n\nAside from the baseline period, efficacy evaluations will be conducted periodically during the treatment phase after cell reinfusion until the occurrence of one of the following events, with the earliest event taking precedence: disease progression, initiation of new anti - disease treatment, death, intolerable toxicity, the investigator's decision, or the subject's voluntary withdrawal."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Age ≥ 18 years (including the cut - off value), with no restrictions on gender.\n2. Expected survival time ≥ 3 months.\n3. Subjects with relapsed/refractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n4. Liver and kidney functions and cardiopulmonary functions meet the requirements.\n5. No severe mental disorders.\n6. Able to understand this trial and have signed the informed consent form.\n\nExclusion Criteria\n\n1. Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.\n2. Subjects with positive virus and/or syphilis tests.\n3. Presence of severe heart disease or unstable systemic diseases.\n\n5\\. Presence of active or uncontrollable infections requiring systemic treatment.\n\n6\\. Pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.\n\n7\\. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening."}, 'identificationModule': {'nctId': 'NCT06970951', 'briefTitle': 'Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'PersonGen BioTherapeutics (Suzhou) Co., Ltd.'}, 'officialTitle': 'A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases', 'orgStudyIdInfo': {'id': 'PG-009-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UTAA91 injection', 'description': 'Infusion of UTAA91 injection in subjects screened after signing informed consent.', 'interventionNames': ['Biological: UTAA91 injection']}], 'interventions': [{'name': 'UTAA91 injection', 'type': 'BIOLOGICAL', 'description': 'Infusion of UTAA91 injection in subjects screened after signing informed consent.', 'armGroupLabels': ['UTAA91 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jian Wu, Doctor', 'role': 'CONTACT', 'email': 'njwujian@163.com', 'phone': '+86-15358805676'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Jian Wu, Doctor', 'role': 'CONTACT', 'email': 'njwujian@163.com', 'phone': '15358805676'}], 'overallOfficials': [{'name': 'Jian Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PersonGen BioTherapeutics (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}